Patheon Biologics B.V.
FDA inspection history in Groningen, Netherlands, 2018
- 1
- Form 483
Every document, by year
- Form 483
2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Groningen, Netherlands.
Cited most
Across all Patheon Biologics B.V. observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.160General requirements1
- 21 CFR 211.182Equipment cleaning and use log1
- 21 CFR 211.192Production record review1
The complete Patheon Biologics B.V. file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Groningen, Netherlands
One Form 483 · 2018 · 10 observations
Latest: Form 483, Feb 13, 2018 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-02-13 | 483 Form 483 | Groningen, Netherlands | 10 | $99 |
Investigators on these documents
Oa C. Barragan (1)Patrick Lynch (1)Ravens A. Barragan (1)Ve -. Barragan (1)Vere Le X. Barragan (1)Wayne Seifert (1)
FEI number 3002608687 · most recent document Feb 13, 2018
About Patheon Biologics B.V.
How many FDA Form 483s has Patheon Biologics B.V. received?
FDA Intel has 1 Form 483 on file for Patheon Biologics B.V.; the most recent is dated Feb 13, 2018.
When was Patheon Biologics B.V. last inspected by FDA?
The most recent FDA inspection document on file for Patheon Biologics B.V. is a Form 483 dated Feb 13, 2018, for the site in Groningen, Netherlands.
What did FDA cite at Patheon Biologics B.V.?
The regulations cited most in the observations on file for Patheon Biologics B.V. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.142 (Warehousing procedures), 1 time; 21 CFR 211.160 (General requirements), 1 time.